510(k) K991608

DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING by Dermaphylyx, Inc. — Product Code KMF

K991608 is an FDA 510(k) premarket notification submitted by Dermaphylyx, Inc. for the device "DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING". The FDA issued a decision of Substantially Equivalent on July 20, 1999. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Dermaphylyx, Inc. has at least 8 other 510(k) clearances on record.